
"The Patent Eligibility Reform Act (PERA) 2025 changes only one aspect of the proposed new text for § 101: human genes that are merely 'isolated' will remain ineligible, which is essentially illusory since few useful claims will fail to meet the latter criteria."
"The criticisms of our current patent eligibility regime are familiar. The Supreme Court's reshaping of patent eligibility was based largely on its economic hunches, rather than the careful study such a foundational doctrine deserves."
"In biomedicine, the United States has almost unintentionally backed into a regime where nearly all methods of diagnosis are ineligible, but nearly all methods of treatment are eligible, again with no economic justification for why that should be the case."
The Patent Eligibility Reform Act (PERA) reintroduced in 2025 modifies patent eligibility for human genes, maintaining ineligibility for isolated genes not altered or used in inventions. Critics argue the current patent eligibility framework, shaped by the Mayo/Alice decisions, misinterprets historical intent and lacks economic justification. The Supreme Court's decisions have led to a situation where diagnostic methods are largely ineligible while treatment methods remain eligible. PERA seeks to clarify patent eligibility but faces challenges in addressing these longstanding issues.
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